This is an editorial decrying the FDA decision to de-approve Avastin Rx for breast cancer, noting, "The decision betrays a bias that puts costs above treatment, and unless the FDA leadership overrules its own experts, the 40,000 women killed by breast cancer each year will be denied an important clinical option."

Oh nelly. Here's what's wrong with their thinking:

"Roche's Genentech unit charges as much as $88,000 annually for an Avastin breast cancer regimen, reflecting the costs of development and production."

They go on to admit Avastin does not prolong life, only progression free survival. In other words, your breast cancer appears the same size a bit longer, then kills you at the same time it would have without the drug. Why does this matter? For:

"minimizing psychological suffering and offering hope."

Hope that you won't have your life extended? How about... an antidepressant (essentially free)? A spiritual counselor (you can have your own, full time, for 90k a year!)? Wait, how much time are we talking about?

"Critics claim these effects are worthless because they translate into only one to three extra months before tumors worsen."

That's it: 4-12 weeks of not being told your cancer got worse. Know how else you can accomplish that? SKIP A CT SCAN. Many cancer patients get serial scans just so we can tell them their tumor is shrinking or growing; they experience no change in symptoms from this. Unless a scan is absolutely required for treatment decisions, skip em. We know that imaging costs especially for cancer are skyrocketing. We're spending billions giving people drugs and scanning them often just so we can comment on tumor size and progression when these scans and drugs offer no meaningful benefit to patients. Super! What else you got, editorialist?

"The median overall survival benefit for one subgroup of 496 patients between the ages of 40 and 64 was an additional 5.7 months of life. Some individuals gain years. At any rate, even the 31% reduction in the risk of disease progression or death is better than the status quo."

Ah, I love being lied to. Here, they're pulling one subgroup out of one trial and inflating that mortality benefit as a bit of hope cancer patients can fixate on. There may be mortality benefits to some and not other patients, but the same editorialists admit,

"Patients did not live longer."

The summary experience is that it doesn't prolong survival. Because of random variation, especially in subgroup analyses, there may appear to be signal when there is just noise. OVERALL, what do we know, what do they admit? No prolongation of life. Why, if they claim some patients get another half year? Well, some breast cancer patients life many many years with metastatic disease. Without Avastin. Avastin can't claim credit for a few long term survivors; that's just cancer. And further, Avastin has

"...safety issues such as toxic side effects. The latter can include severe bleeding and other life-threatening complications, though they are manageable."

So guess what? Even if we assume they're right that some people live longer because of Avastin, there is an equal and opposite harm from life threatening (I would say life ENDING) effects. That's why "no overall surivival benefit"). You are spending 90k a year to prolong life as much as you shorten it.

Now, I'm not totally against approving this drug, and letting doctors and their patients decide the risks, but the editorial notes,

"But private insurers and Medicare are reluctant to cover treatments that aren't recommended by the FDA."

No Sheet! I would NEVER propose that medicare or private insurance go towards a therapy that extends "progression free survival" and not survival for 1-3 months at a cost of 90k a year. THAT expense, let's remember, is between $360,000 and $1,080,000 for year a patient goes without hearing their cancer is worse on a scan without any difference to their clinical outcome.

Do we have $360-1080k to spend on a year of progression freedom? NO!

Do we have $360-1080k to spend on a year of SURVIVAL benefit (with metastatic cancer)? NO!

Do we have $360-1080k to spend on even a QALY (a QUALITY year of life)? NO!

If you think about it, there is simply no way an average American can contribute enough to the medical resoures we have to spend to receive this therapy. Treatments this expensive are NOT sustainable; we will NOT be paying for them in the future, as we will either decide not to (we will give up on our "any expense" rescue fantasies for dying patients and focus on more cost effective therapies that prolong quality years, prevent disease, and treat ill people more efectively) OR we will be forced not to pay for these things because we can't (I wonder if Greece is paying for Avastin these days, hmmm). A more reasonable limit for a QALY is like 50 to maybe $100,000 (note: topic of bitter debate). IF this medicine were approved, it would be terribly unwise to require medicare or insurers to pay for it. Perhaps people who want such terribly inefficient healthcare could pay double or triple rates IN ADVANCE for this protection, just as they may pay more for "replacement cost" or "no deductible" home or car insurance. But we must not demand these things.

This is really pathetic. If and when we are really sick, we can think about more than ourselves and also about the state of the system we'll be leaving behind (in this case, at the same time of departure). And know that if a therapy is denied for being marginally useful, it's not a big deal anyway: it's a marginal therapy. THAT kind of reason in the face of illness will never come about while we're reading editorials like these. *I* for one am more worried about what I can do for the length and quality of my life (living right) than I am about such barely useful treatments I may need when terminally ill. Most people would live longer if they spent their time on a brisk walk than on moaning to the FDA about this.

Yeah, that was a great rant. I totally agree. "All-costs" therapies are irrational, and even simply "expensive" therapies need to work reasonably well for their costs to be shared among all of us. It's as if people think they might just live forever...

One part of the cynicism I bring from my graduate biomedical engineering training is a penchant for some to love technology for its own sake. For example when I was in the "ABD degree" stage (All But Dissertation), I was working in cardiology research using echo to image the heart and hopefully one day use contrast agents to estimate tissue blood flow. Well I recall a fellow grad student putting an enormous amount of effort and time into getting MRI images of a heart cycle. The rest of the department was wowed by it. And my comment? Why???? You just spent an hour vs. a few seconds getting one cycle vs. several cycles of heart wall motion for tens of thousands vs. a few hundred bucks. And all that to get an image that's certainly better, but it gives no additional information that a good echo couldn't give with a good cardiologist reading that echo.

If the FDA doesn't approve a drug, it's usually because it doesn't improve morbidity or mortality, or is no better than something else that costs less. It is what it is.

On another note... A great article in the literature recently how palliative care for terminal cancer patients can actually extend lives for a few months (on average). That's good news... except that others were commenting that it was a good reason to give curative care AND palliative care AT THE SAME TIME. So... there is no "cost savings" when the palliative care lobby is trying to get insurance companies to pay for their gig in the widest possible set of circumstances. And you know what? That's actually pretty typical.

Today I admitted (pertinent details fuzzified to protect privacy) a 62 year old man who has had a stroke, chronic lung disease, and heart disease. But that's the least of his problems. He has been completely unresponsive for 5 years due to anoxic brain injury, and lies there getting tube feeds, breathing through his neck, getting pneumonia after pneumonia, urinary infection after urinary infection, and he is still "full care, full code," or in "do everything" mode. Ostensibly I'm supposed to bang on his chest and try to shock his heart back to life if his body realizes what's going on and tries to shut down. Why? He said one sentence years ago: when asked if he wanted to be kept alive if he was "very sick," he said yes. And everything since his anoxic brain injury has been punishment for that.

Oh, did I mention? He has metastatic prostate cancer. Diagnosed years ago, and this unresponsive person has been getting chemotherapy and hormonal agents to slow the progress of this fatal disease. What insanity... even if he DID ask for all of this stuff, what kind of an a$$hole would seriously say "yes" if asked, "would you like millions of dollars to be spent on your years of futile care when you are a vegetable with cancer instead of going to kids who need vaccines or diabetes research or other meaningful causes?"

When we run out of healthcare dollars, we'll have to explain this to our kids. That and the Hummers we drove with the last of the gasoline.

Perhaps... just perhaps he got so fed up at all the money he was being robbed of that he decided at that point that he wanted to "punish" the system in exactly this way. Being a vegetable now there is no way for him to reverse it. So perhaps... just perhaps having to go through all of this rather than pass peacefully is the other edge of the sword slicing back at him.

Just maybe... another lesson that there are always consequences to all of our decisions. He may very well be "conscious" at some level in there and in a "living" hell...

Well, I don't blame him for saying "yes". I myself want to be kept alive if I'm "very sick". Lots of "very sick" patients walk out of the hospital a couple of weeks later, and if I had a chronic disease, maybe I might already have been one of them. The problem is that this is a horrifically oversimplified question. The real answer is an essay discussing the interplay of prognosis, hope (possibility of besting the prognosis), cost, etc. And the older I get, the closer I get to a natural death, the more weight I would give to the negative consequences for others. It's not a living will that I want to sign off on, it's a decision tree that works kind of like a tax return. I know it's a serious subject, but the thought of Ian with a clipboard working through tax-return-like a decision tree that requires him to do arithmetic to decide my fate is making me laugh.

Mike hit it on the head. The family is treating this complex human like he can be summed up with a single sentence. There is no way he meant that he wanted this (and we shouldn't offer it, if he did). His family knows it's an awful spot, but feel tied to this one sentence. I'm trying to get them to reconsider all the other things he's said over his life and the limits to what he meant (all statements have exceptions), but being involved in his care for several days only after years of this nonsense, I don't think my chances are good. At least, the primary decision maker is reasonable and willing to engage.

There is no way he meant that he wanted this (and we shouldn't offer it, if he did).

Well maybe he didn't and then again maybe he did. My problem is in your statement that we shouldn't offer it if he did. That's the only thing I disagree with Mike about... the thought of Ian(or anyone) standing over me or anyone else (especially someone I love that has made their feelings known to me) with an actuarial clipboard deciding whether treatment should be provided isn't funny at all... it's sad, maddening and downright scary!

If he paid into the system for all those years with a perception that he didn't get back what he was/did put in, then I don't have a problem with you having to continue to follow his wishes. If you don't agree with doing that, then perhaps you aren't the right person for this case. Maybe I would make a different decision/statement than he made, but I also know that both private insurance and the Federales have gotten a lot from many people that they have basically redistributed to others (including and especially themselves), so I can understand the attitude that someone might want them to pay and pay and pay and... etc. for their benefit. (actions have consequences... when insurance and/or government screws people over long enough, those people start getting exactly the type of attitude such as this.)

Evidently for some it's nothing more than a matter of "how much it costs" vs. "what the benefits are". I am probably one of the strongest self-proponents of that, but rationing care (which was done to me to a very large extent by an insurance company a little over 18 months ago on a treatment so that they could save $3-4k... costing me an additional 3 months to get healthy on my own which also cost me & my employer in those additional 3 months of less productive time... when MY part of the premiums to that insurance company are well over double that amount - not to mention the fact that my employer pays more than I do) well... Personally, that's just wrong. In the specific case that Ian describes the costs are way out of proportion with the benefit. WAY out of proportion. But I can understand why he might have actually meant what he said in that one sentence.And I know of a lot more examples of folks getting screwed by insurance companies and/or the government... and it's only getting worse with the new attitude of eff the old people, let em die...

"the thought of Ian(or anyone ) standing over me or anyone else (especially someone I love that has made their feelings known to me) with an actuarial clipboard deciding whether treatment should be provided isn't funny at all... it's sad, maddening and downright scary!"

It's scary to be deathly ill or to think of oneself as unable to respond and speak for oneself, no doubt. But we can't let that emotional response to the situation result in the collapse of healthcare for all. IMHO.

"If he paid into the system for all those years with a perception that he didn't get back what he was/did put in, then I don't have a problem with you having to continue to follow his wishes. If you don't agree with doing that, then perhaps you aren't the right person for this case."

I'm not sure what you mean about his perception, but, it doesn't matter if he paid into the system his whole life. I might claim that I paid into the system so I get to have heavy metal therapy for my cancer. No, I don't; that wouldn't work, so we're not offering it. What if someone wants their demented 100 year old relative on life support for another 3 months after a massive stroke and heart attack with no chance of recovery? We CAN do that, but even if resources were unlimited (and they're not) I don't think we SHOULD. The therapy has no chance of providing a meaningful benefit and is very expensive and is burdensome to the patient = do not provide. Now, we can, and we do; hospitals make big bucks hurting people and wasting resources this way, often because relatives tell them they must, or because what difference is it to the hospital if medicare pays? But it's wrong. Ask not, should we keep the 99% dead person alive another few months at high cost; ask, should we keep the 99% dead person alive another few months at high cost or should we improve the vaccination of children, provide cancer screening which can save lives, and better control diabetes and hypertension or improve post heart attack care? THAT's an easy one, and this IS a zero sum game, even before we go bankrupt.

Rationing care is "wrong" to some extent, but it happens. This is a fact. All the time, right here in the USA. It will happen; it must. We cannot pay for all that we CAN do. Our options are to spend on our Chinese credit card because we can't say no even to worthless therapies, then go broke and give up useful and vital therapies. Or we could look at our resources and say, how should we spend this? In the way that offers everyone the best shot and best care possible? Or one that wastes most of the money on the dying process and keeping people in a miserable inhuman state instead of compassionate hospice care for the seriously ill?

Let's look at a specific case: liver transplant. It must be rationed. Currently we give the livers to the sickest possible people. Ones on death's door. As a result the survival rate is reduced and the precious organs go wasted at extremely high cost. This is "each according to need." Another way we could do it is to give the livers to those who are not as sick, but definitely need them soon, improving survival. This is "each according to greatest benefit overall." Which would people want? Well, if you ask people only when they're on death's door, they say they still want a chance. But if you ask a 1000 minimally ill patients with progressive liver failure which system they would want, they would no doubt choose the system that improves their life expectancy the most, which would mean that all, fairly, are evaluated and ranked by need and kicked off the list when they got too sick to safely get the liver. This is hard to tell people in person. It's easier to say, "we'll always fight for your chance to get a liver, your individual doctor has no interests above yours." But that tragedy of the commons reduces the life expectancy of everyone in the system.

No rationing is not a solution; when someone says that, ask them, no no, I understand you don't like the idea of it, but since it is inevitable, how do you propose we do it?? So how would you allocate livers? The way that works the best or the way that appeals to the American rescue fantasy, of waiting for the disaster and then sparing no expense? IF you'd give the livers to the sickest patient, would you say the same if you had progressive liver disease and you knew a more dispassionate solution would improve your chances? And still be completely fair??

NB: I found the decisions made about this patient's care to be absurd and offensive, but he still got the very best of western medicine. I merely tried to get through to the family who is selfishly wasting your tax money on futile care we. simply. cannot. afford. And I would say torturing a loved one in the process.

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